Quality Data...Delivered by Design™

Quality Data...Delivered by Design™

Services and Solutions for Smaller Companies and Biotech

Are you an emerging company struggling with the decision whether to hire internal staff, hire individuals from a staffing agency or use a CRO to conduct your trials? Your key concerns are probably:

  • Control
  • Cost
  • Quality
  • Speed
  • Therapeutic expertise
  • Clinical trial expertise
  • Staff quality

What should be your decision?

In fact, for small companies and biotechs, outsourcing is less expensive than building a clinical team in-house.

You may decide that hiring employees would satisfy the control and cost criteria since it appears to be cheaper than using a CRO. Actually, hiring new internal employees or using a staffing agency may cost more since there is no infrastructure to support your new hires or contract staff. Emerging companies often lack infrastructure (processes and expert management) to support the growing company as they are focusing on product development... as they should be.

For small pharma/device/biotech companies the decision to use a CRO vs. hiring new staff is usually based on cost. However, most cost analyses in these companies compare the cost of the individual staff in each area. For example, they compare the cost of a CRO monitor against an employee monitor and find the employee salary less costly. This cost analysis does not account for the true cost of using employee monitors in a start-up company. Since a smaller company typically has little or no infrastructure, standard procedures, or a history on how studies are conducted, precious time is spent designing and implementing these things while they are starting up the study. With the typically limited staff to begin with, working on the study takes priority over infrastructure. The result is many and frequent internal meetings wasting time on “how do we do this” before each activity is performed. A CRO is actually more efficient and less costly since the infrastructure, the efficiency and the experience is in place. Another facet of the cost equation for internal hires, needed management to manage the new staff and training them to ensure performance standards are met, adds additional cost that is rarely considered. Since the CRO already has the management structure, trained personnel and training programs, it is more cost-effective.

To solve this problem small or boutique CROs can serve as part of the virtual clinical team to conduct the trials while the emerging company maintains a clear focus on its core competency… product innovation and development. The small sponsor will receive the benefits as the CRO provide its core competency… providing the expertise and work force to conduct the trials successfully. It has been reported extensively that when CROs provide their core competencies, clinical trials are completed faster (analysts report up to 30% faster) and at a lower cost due to experience and time tested processes.

Decades of experience at all CRO levels in a boutique CRO minimizes trial risk factors, provides the expertise to smaller companies who may not have it internally, and provides a high level of confidence for the sponsor.

In the CRO partnership, there is no “one size fits all”. Certainly a large CRO can conduct a small trial or work with a small company but both will get lost in the volume of large clients with large projects. Biotech clients have the special needs of flexibility and adaptability throughout their clinical trials program. The CROS working with biotech need to be able to flex and adapt to the changing requirements of these trials.

Although CRO services appear to be a commodity, each Sponsor/CRO relationship is different and critical to the result of the project. Small to mid size companies want to work with a similarly sized CRO so the relationship can be built to survive the difficulties of clinical trials. It’s always the relationship that affects the services. The size of the CRO is not as important as the quality of the execution and the commitment to the trial. Research Dynamics is known for its dedication, execution, and perseverance in every trial it conducts.